A Study of Brain Receptor Occupancy in Healthy Subjects
Assessment of Brain Kappa Opioid Receptor Occupancy After Single Oral Doses of LY2456302 as Measured by PET With Radioligand LY2879788 in Healthy Subjects
2 other identifiers
interventional
13
1 country
1
Brief Summary
To measure the occupancy of brain kappa opioid receptors after single oral doses of LY2456302.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2010
CompletedFirst Posted
Study publicly available on registry
November 2, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedMay 9, 2011
May 1, 2011
4 months
October 20, 2010
May 5, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Change in brain kappa opioid receptor occupancy (RO) by positron emission tomography (PET)
Baseline, after single dose of study drug
Secondary Outcomes (3)
Pharmacokinetics, area under the curve (AUC)
Days 1 and 2
Number of participants with clinically significant effects
Baseline to study completion
Pharmacokinetics, concentration maximum (Cmax)
Days 1 and 2
Study Arms (1)
opioid receptor kappa antagonist
EXPERIMENTALInterventions
Starting dose of 2 mg, administered orally, once. The potential dose range for this study is 0.2 mg to 30 mg
Eligibility Criteria
You may qualify if:
- Healthy male or female
- Have clinical laboratory tests within normal reference ranges
- Have arterial and venous access sufficient to allow blood sampling
You may not qualify if:
- Currently enrolled in, or discontinued within the last 30 days from a clinical trial
- History of severe allergies or multiple adverse drug reactions
- Have an abnormal ECG at screening visit
- Have abnormal sitting blood pressure
- Have an increased risk of seizures
- Current suicidal ideation
- Positive test for HIV, hepatitis C, or hepatitis B
- Women who are breast feeding
- Smoke more than 10 cigarettes per day, or equivalent
- Drink more than 5 cups of coffee per day, or equivalent
- Have a history of head injury
- Unable to undergo a MRI
- Suffer from claustrophobia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
New Haven, Connecticut, 06519, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 20, 2010
First Posted
November 2, 2010
Study Start
December 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
May 9, 2011
Record last verified: 2011-05